The document outlines the evolution of pharmaceutical legislation in India from the late 19th century to the mid-20th century, highlighting the issues of drug quality and regulation. It details various committees, such as the Drug Enquiry Committee and the Bhore and Hathi Committees, and their recommendations for establishing regulatory frameworks and ensuring quality control in the drug market. Key legislative milestones include the enactment of the Drugs and Cosmetics Act, Pharmacy Act, and the Indian Pharmacopoeia, which aimed to improve drug safety and professional standards.

1. P. NAGA CHANDRIKA
M.PHARMACY
ASSIT.PROFESSOR

2. • INTRODUCTION
• ORIGION AND NATURE OF
PHARMACEUTICAL LEGISLATION
• DRUG ENQUIRY COMMITTEE
• ASPECTS OF COMMITTEE
• RECOMMENDATIONS
• OUTCOMES OF THIS COMMITTEE(CENTRAL)
• STATE ACTs
• TYPES OF COMMITTEES

3. INTRODUCTION
 At the end of the 19th century and early 20 century use of
Allopathy system increases
 Drugs of natural origin: Veg, mineral oil and animals
 At that time, profit became main motive than service
 Overdose of quinine
 Using croton oil in eye instead of atropine solution
 In adequate dispensing and selling
 Excellent dumping of drugs
 Drugs are badly adultered
 Instead of quinine, chalk tablets is used
 Drugs like satonine were badly adultered
 Potent drugs like antimony , arsenic and digitalis marketed
without any standards
 Leading article published by Indian Medical Gazette (1927-1929)
“India become a land of quacks, of quacks doctors, quack medicine mongers, quacks
dentists, quacks of medicines, quacks of opticians, quack of faith healers”
There was practically no legislation to control on drugs as well as on the pharmacy
profession.

4.  Earlier, the allopathic system of medicine was brought by
Britisher’s to our country and allopathic medicines were
mainly imported
 To have some control on the import, the British Rulers
introduced
 The Indian Merchandise Marks Act 1889
 The Sea Customs Act 1898
 Indian Tariff Act 1894
 The Opium Act 1878
 Poison Act 1919
 They were not comprehensive enough to control the chaotic
and deplorable conditions in the drugs trade and industry.

5.  On representation from the Indian people,
the Viceroy appointed a committtee On 11th
August,1930, under the chairmanship of
Col. R.N. Chopra.
 So, this committee also called its viceroy
committee/R.N.Chopra committee/Drug
Enquiry committee.
 The report was published in 1931.
 The committee aspects were

6. 1) To enquire into the extent to which drugs and
chemicals of impure quality or defective strength,
particularly those recognized by the British
Pharmacopoeia are imported, in the public interest,
of controlling such importation, manufacture and
sale and to make recommendations.
2) Recommendations to overcome the above.
3) The enquire into the necessity of legislation to
restrict the profession of pharmacy to duly qualified
persons and to make recommendations.

7. 1) A Central law to control drugs and pharmacy profession.
2) Setting up of test laboratories in all states to control the
quality of production of drugs and pharmaceuticals and a
control laboratory to control the quality of imported drugs
and also to act as expert referee in case of disputed
samples sent by local Governments.
3) Appointment of an Advisory Board to advise the
government in making rules to carry out the objects of the
Act.
4) Setting up of courses for training in pharmacy
minimum qualification for registration as a

8. 6) Registration of every patent and proprietary
medicines of undisclosed formula manufactured in
India or imported from outside the country.
7) The crude single drugs as well as compounded
medicines used in indigenous system of treatment,
should be brought under control.
8) The drugs industry in India should be developed.
9) Gradual reduction of manufacturing in Medical
Stores Depots.
10) Compilation of an Indian pharmacopoeia .
11) The Cinchona Department should cultivate
Cinchona.

9. 1. Enactment of IMPORT OF DRUGS BILL 1937.
2. DRUGS AND COSMETIC ACT 1940 and Rules
1945.
3. PHARMACY ACT 1948
4. DRUGS AND MAGIC REMEDIES (Objectionable
Advertisement) ACT, 1954 and Rules 1955.
5. MEDICINAL & TOILET PREPARATIONS (Excise
Duties) Act, 1955 and Rules, 1956.

10. 6. Publications of first edition of INDIAN
PHARMACOPOEIA in 1955 based on
British pharmacopoeia 1948
 1st Edition - 1955
 2nd Edition - 1966
 3rd Edition - 1988
 4th Edition - 1996
 5th Edition - 2007
 6th Edition - 2014
 7th Edition - 2018

11.  BENGAL: Bengal Municipal Act 1884
Bengal Food Adulteration Act 1999
Bengal Excise Act 1909
 MADRAS: Madras prevention of Adulteration
Act 1919
 UTTARPRADESH: United Provinces Municipal
Act 1916
 PUNJAB: Pure Food Act 1929
Municipal Act 1911
 BIHAR AND ORISSA: Bihar and Orissa municipal
Act 1922
Prevention of Adulteration Act 1919
Excise Act 1914

12.  BHORE committee
 BHATIA committee
 MUDALIAR committee
 HATHI committee

13.  October 1943---Health Survey and Development
Committee – by Govt of India
 Chairman----Sir Joseph Bhore.
 COMMITTEE RECOMMENDATIONS:
 Establishment of an All India Pharmaceutical Council
and provincial Pharmaceutical Council
 Strengthening of profession standards of pharmacists
 Maintaining disciplinary control
 Starting of revised courses of study
 Setting up of Central Drug Laboratory
 Rigid enforcement of the Drug and Cosmetics Act,
1940

14.  Government of India in 1953---Appointed
 Pharmaceutical Enquiry Committee
 Chairman---Major-general S.L.Bhatia
 Made a comprehensive enquiry into the
working of pharmaceutical industry.
 In June 1954, 212 recommendations have
been implemented.

15.  In 1959, Healthy Survey and Planning
Committee appointed
 Chairman- DR.A. LAKSHMANSWAMY
MUDALIAR
 Recommended the inclusion of indigenous
systems of medicine under the purview of the
Drugs Act.

16.  Important milestone in pharmaceutical
legislation history is Hathi Committee
 Chairman- JAISUKH LAL HATHI
 This committee covered all the aspects of
 Licensing, price control, imports, role of
foreign sector quality control.

17.  A text book of Forensic Pharmacy –
B.M.Methal
 A text book of Pharmaceutical Jurisprudence
&Ethics—Dr.S.P.Agarwal & Dr. Rajesh Khanna
 A test book of pharmaceutical Jurisprudence –
K. Sampath
 A test book of Forensic Pharmacy –N.K. Jain

18. THANK YOU